ATC725, ATC525, AND AP300— 510(k) K922165

Substantially Equivalent

Gendex Corp.

FDA 510(k) clearance K922165 for ATC725, ATC525, AND AP300, Substantially Equivalent on 1992-07-27. Applicant: Gendex Corp.. Device class: 1.

Clearance details

Applicant: Gendex Corp.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1992-05-08
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.